NCT03506763

Effect of Pre-medication in Pain Measures on Office Hysteroscopy

Effect of Pre-medication in Pain Measures on Office Hysteroscopy - Randomized Clinical Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 231 (estimated)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Will be perform a RCT to compare pain measure on office hysteroscopy after pre-medication with oral analgesic. Patients will be alocate to oral sodic diclofenac, scopolamin or placebo. We will compare visual analog score of pain after the procedure. Patients: patients with indication of office hysteroscopy to evaluate uterine intracavitary abnormality. Interventions Group 1 (control) The patients will receive about 2 h prior to the procedure 2 placebo tablets. Group 2 (diclofenac + scopolamine) The patients will receive about 2 h prior to the procedure 1 tablet of diclofenac sodium 50 mg and 1 tablet of scopolamine 2 mg. Group 3 (diclofenac only). Patients will receive approximately 2 h prior to the procedure 1 tablet of diclofenac sodium 50 mg and 1 tablet of placebo.

Detailed description

Pain during and 30 minutes after a hysteroscopy will be measured through the visual analog pain scale of 10 centimeters, considering 0 (no pain) and 10 (unbearable pain or the greatest pain ever experienced). Acceptance of the procedure and assessed through the Likert 5-point scale: 1) totally disagree; 2) disagree; 3) I do not agree or disagree; 4) I agree and 5) I totally agree.There will also be a need for analgesia after the procedure, the time spent in the observation room and the onset of vagal symptoms such as dizziness, malaise, nausea, vomiting or syncope

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Placebo Oral + Placebo Oral	Placebo Oral + Placebo Oral
DRUG	Diclofenac oral + Placebo Oral	Diclofenac oral + Placebo Oral
DRUG	Diclofenac oral + scopolamina oral	Diclofenac oral + scopolamina oral

Timeline

• Start date: 2017-08-01
• Primary completion: 2018-12-31
• Completion: 2019-06-30
• First posted: 2018-04-24
• Last updated: 2018-04-24

Locations

1 site across 1 country: Brazil